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Tuesday, 31 March 2009

The birth of new drugs-the hope is still there!

Today:

  1. FDA OKs 1st drug from genetically altered animals
  2. Protein reverses Alzheimer's brain damage
  3. Anti-HIV gel shows promise in large-scale study in women
  4. Chemical drink breathes life into damaged hearts
  5. Engineered bacterium churns out two new key antibiotics
This is one of my most positive posts. All the articles are just very promising and give me the feeling that everything is going to be all right. Enjoy!

FDA OKs 1st drug from genetically altered animals

By RICARDO ALONSO-ZALDIVAR, Fri Feb 6, 5:12 pm ET

WASHINGTON – The Food and Drug Administration made history Friday as it approved the first drug made with materials from genetically engineered animals, clearing the way for a new class of medical therapies.

GTC Biotherapeutics said regulators cleared its drug ATryn, which is manufactured using milk from goats that have been scientifically altered to produce extra antithrombin, a protein that acts as a natural blood thinner.

The drug's approval may be the first step toward new kinds of medications made not from chemicals, but from living organisms altered by scientists. Similar drugs could be available in the next few years for a range of human ailments, including hemophilia.

The FDA cleared the drug to treat patients with a rare hereditary disorder that causes a deficiency of the protein, putting them at higher risk of deadly blood clots.

Patients with hereditary anithrombin deficiency are currently prescribed conventional blood thinners, like Plavix from Bristol-Myers Squibb and Sanofi-Aventis. That will not change with the new approval. ATryn is only approved for use when patients are undergoing surgery or having a baby, times when the risk of dangerous clots is particularly high. Those patients would receive the drug by intravenous infusion for a limited time before and after their procedures.

To make the drug, scientists at GTC put DNA for the human antithrombin protein into single cell embryos of goats. Goat embryos with the gene were then inserted into the wombs of surrogate mothers who gave birth to baby goats that produce the protein-charged milk.

Genetically engineered animals are not clones but rather animals that have had their DNA changed to produce a desirable characteristic.

Consumer groups said the FDA's long-awaited policy will not require all genetically engineered foods to be labeled as such. And they said the government has not done enough to examine the potential impact of genetically engineered animals on the environment, particularly if some escape and begin to mate with animals in nature.

The drug received European approval in 2006. source

My comment: I'm glad this is the first news, because I think it's extremely positive. Not only because adore goats. They are so lovely and their milk is so good for humans, I'm surprised they don't get the respect they ought to have. But in any case, I think this is a good way to create a medicine, because their birth by a normal goat guarantee that they are not too far from Nature. And I'm sure the medicine will save many lives!


Protein reverses Alzheimer's brain damage

Injections of a natural growth factor into the brains of mice, rats and monkeys offers hope of preventing or reversing the earliest impacts of Alzheimer's disease on memory. The benefits arose even in animals whose brains contained the hallmark plaques that clog up the brains of patients.

By delivering brain-derived neurotrophic factor (BDNF) directly into the entorhinal cortex and hippocampus, the parts of the brain where memories are formed then consolidated, the researchers successfully tackled damage exactly where Alzheimer's strikes first.

"We're administering BDNF directly to the degenerating neurons in memory systems of the cortex, and preventing their death," says Mark Tuszynski of the University of California at San Diego. The substance, which naturally supports brain cells throughout life, also amplified the numbers of connections, or synapses, between neurons.

"Our most compelling evidence was the observation that brain cell death was prevented, and that connections between neurons rose in density by about 25%," says Tuszynski. Improvements on this scale happened in all the animals, including mice with a version of human Alzheimer's disease, elderly rats and monkeys with natural degeneration, plus rats and monkeys given brain lesions similar to those seen in Alzheimer's.

To prolong the effects beyond simply injecting BDNF itself, Tuszynski injected a harmless lentivirus carrying the gene for BDNF, so that the chemical would carry on being produced by the virus. He says that pending safety studies, trials could start in two years. source

My comment: Hm, it's true that the procedure is quite invasive, but still, if you can even slow down the progress of the disease, long enough to get a proper treatment, that's not bad for a result at all. And I'm sure they will find a way to make the treatment less invasive and more leasting.

Anti-HIV gel shows promise in large-scale study in women

February 9th, 2009

An investigational vaginal gel intended to prevent HIV infection in women has demonstrated encouraging signs of success in a clinical trial conducted in Africa and the United States.

The study investigators found the microbicide gel—known as PRO 2000 (Indevus Pharmaceuticals, Inc., Lexington, Mass.)—to be safe and approximately 30 percent effective (33 percent effectiveness would have been considered statistically significant). This is the first human clinical study to suggest that a microbicide—a gel, foam or cream intended to prevent the sexual transmission of HIV and other sexually transmitted infections when applied topically inside the vagina or rectum—may prevent male-to-female sexual transmission of HIV infection.

"Although more data are needed to conclusively determine whether PRO 2000 protects women from HIV infection, the results of this study are encouraging," says NIAID Director Anthony S. Fauci, M.D.

The Phase II/IIb clinical trial, which enrolled more than 3,000 women, is NIH's first large clinical study of a microbicide.

"The study, while not conclusive, provides a glimmer of hope to millions of women at risk for HIV, especially young women in Africa," adds lead investigator Salim S. Abdool Karim, MBChB, Ph.D., from the Center for the AIDS Program of Research in South Africa, who presented the findings at CROI. "It provides the first signal that a microbicide gel may be able to protect women from HIV infection."

Currently, women make up half of all people worldwide living with HIV. In sub-Saharan Africa, women represent nearly 60 percent of adults living with HIV, and in several southern African countries young women are at least three times more likely to be HIV-positive than young men. In most cases, women become infected with HIV through sexual intercourse with an infected male partner. An effective microbicide could provide women with an HIV prevention method they initiate. This would be particularly helpful in situations where it is difficult or impossible for women to refuse sex or negotiate condom use with their male partners.

In the final analysis, 194 women in the study became infected with HIV. Of these infections, 36 occurred in the PRO 2000 group, 54 in the BufferGel group, 51 in the placebo group and 53 in those who did not use gel. Based on these data, PRO 2000 was 30 percent effective, while BufferGel had no detectable preventive effect on HIV infection. Both PRO 2000 and BufferGel were found to be safe.

A separate clinical study sponsored by the Medical Research Council (MRC) and the Department for International Development of the United Kingdom that is currently testing PRO 2000 (0.5 percent dose) in preventing HIV infection among women in Africa could provide further insight into the microbicide's effectiveness. That Phase III study involving nearly 9,400 women is set to conclude in August 2009. source

My comment: Hm, I kind of question the ethics of this research. Sure, those women would have gotten infected anyway, they were counceled and stuff, but somehow, I dislike the idea that those scientists just went there and watched what happens like a statistics. Don't know. Maybe they were right, you have to do the science for the living. Also I question the idea that women that cannot deny sex or make the man wear a condom, will be able to have the time to put that gel. Especially when most of them are raped. But anyway, the gel could help women on the west too.

Chemical drink breathes life into damaged hearts

After drinking a chemical dissolved in water, mice with damaged hearts turn from couch potatoes into treadmill tearaways, researchers say. The finding raises hopes that the same substance can invigorate patients weakened from heart attacks by increasing the supply of oxygen to damaged cardiac muscle.

Designed to make haemoglobin release more of its oxygen than normal, the drug, myo-inositol trispyrophosphate (ITPP) boosted exercise levels in the ailing mice by 35% when given dissolved in water. When given by injection into the abdomen, exercise levels rose a massive 60%.

"ITPP doesn't deliver oxygen itself, but makes haemoglobin able to release a larger amount of oxygen to tissues," explains Jean-Marie Lehn of the University of Strasbourg in France.

Normally, he says, haemoglobin releases only 25% of its oxygen cargo during one circuit of the body. But when ITPP binds to haemoglobin, it releases 35% more than usual, boosting supplies of oxygen to tissues without people having to inhale any extra air.

Further evidence of increased oxygen supply came from blood samples taken from the mice showing a fivefold reduction within just three days of hypoxia-inducible factor, a chemical distress signal produced by oxygen-starved tissue. The results also suggested that the effects from a single dose could last almost a week, so patients wouldn't need to take ITPP every day.

As a result, Lehn hopes to begin clinical trials "as soon as possible". For athletes tempted to use the substance to enhance performance, he warns: "It could be very easily detected." source

My comment:Also a great news. Poor mice that got hyperactive, but the first application that comes to my mind is to use this like an emergency kit-like in army, in a disaster or any other situation requiring to get the most out of your body. That really could make a difference for many people. Especially for those with a heart deficiency-it would be like bringing them back to life. I hope they develop it even more.

Engineered bacterium churns out two new key antibiotics

February 18th, 2009 by Terry Devitt

(PhysOrg.com) -- In recent years, scientists have isolated two potent natural antibiotics — platensimycin and platencin — that are highly effective against bacterial infection, including those caused by the most dreaded drug-resistant microbes.

Now, those two promising agents are a key step closer to augmenting a depleted antibiotic pipeline with the discovery of a genetic pressure point that can send a bacterium that makes both antibiotics into overdrive.

In a report in the online editions of the journal Antimicrobial Agents and Chemotherapy, a team led by University of Wisconsin-Madison professor of pharmaceutical sciences and chemistry Ben Shen shows that a South African soil microbe can be engineered by manipulating a single gene to make large amounts of both antibiotics.

The compounds are among the first discovered in the past 40 years that represent a new class of antibiotics and that exhibit a new mode of action. They work by targeting an enzyme used to make the fatty acids critical for building the cell membranes on the surface of pathogenic bacteria. The need for new antibiotics is significant and growing as pathogenic bacteria are evolving resistance to currently available antibiotics, with some infections becoming almost impossible to treat.

The new Wisconsin discovery is notable because it provides a blueprint for the manufacture of large amounts of antibiotic, a key step in the commercial development of any drug. The team showed that a liter of the engineered bacterium Streptomyces platensis can churn out as much as 300 milligrams of antibiotic, more than 100 times the amount produced by wild strains of the bacterium.

"That's a lot of material," says Shen. "We didn't even optimize production."

The conversion of ordinary Streptomyces platensis into a lean, mean antibiotic-producing machine required the manipulation of only a single regulatory gene, according to the new study. By deleting the gene from the bacterium that produces the compounds, the Wisconsin team was able to find strains of the bacterium that overproduced the antibiotics. source

My comment: Also very very nice. Though, we must make no illusions, the bacteria will find a way to outrun even those antibiotics, but now, at least we'll have a chance to compete with their immense ability to evolve. Cool.

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